Hallucinate, Medicate, and Regulate | The Regulatory Review

Kenny Stills, Aaron Rodgers and many other professional athletes explanation Significant improvement in mental health. what’s the secret? The answer is, perhaps as athletes say, psychedelic.

Hallucinogens, or psychedelics, are substances that cause perceptual distortions and changes in cognitive processes. Psychedelics can be produced synthetically or found in natural substances such as plants and fungi. The most common psychedelics include LSD, also known as acid, MDMA, also known as ecstasy, and psilocybin, the active chemical in hallucinogenic mushrooms.

Stills and Rogers clearly describe the use of psilocybin and ayahuasca, another plant-based hallucinogen, to improve mental health. . Several recent studies have shown that psychedelics may help treat mental health disorders such as depression and post-traumatic stress disorder (PTSD) that affect millions of Americans each year. shown.

If these drugs are useful, what prevents psychiatrists from prescribing psychedelics to their patients?

According to some experts, the stigma surrounding psychedelic use has hampered its development. Government and non-profit campaigns, including the so-called War on Drugs, have preached anti-drug messages to children and teenagers for decades.

Regulatory barriers also prevented researchers from effectively investigating the potential health benefits of psychedelics. classified into different regulatory categories. Under this structure, the government has since classified many psychedelics as Schedule I substances. This means that they are currently not approved for medical use, have a high potential for abuse, and are subject to criminal penalties for unauthorized use. Researchers must obtain approval from the US Drug Enforcement Administration (DEA) to conduct research on Schedule I substances.

But the social stigma surrounding psychedelics may be fading. A recent survey found that 65% of Americans struggling with mental health want access to hallucinogens as a cure. Cities such as Detroit have already taken steps to decriminalize psychedelics.

Pharmaceutical companies may soon submit several psychedelic drugs to the U.S. Food and Drug Administration (FDA) for approval to treat mental disorders, according to reports. In July 2022, the Biden administration indicated that it expects the FDA to approve MDMA and psilocybin to treat PTSD and depression. And he said the DEA also backed out of an earlier proposal to classify the five psychedelics as Schedule I substances, giving scientists room to study their medicinal properties.

This week’s Saturday seminar brings together scholarships to discuss obstacles to the development of psychedelic medicine and how these drugs are regulated for use in healthcare.

• In an article published in NYU Journal of Legision and Public Policy, Mason Marks, of the Petri Fromm Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, analyzes social and legal barriers to the development of psychedelic medicine. Marks argues that the mental health and opioid crises necessitate further investigation of psychedelic use in healthcare. and proposed many ways to amend federal drug laws. For example, removing psychedelics from the DEA’s Schedule I Controlled Substances list, obtaining FDA approval for certain drugs, and decriminalizing and regulating psychedelics. state level. Recent changes to state law on marijuana could also serve as a guide to the decriminalization and development of psychedelic medicine, writes Marks.
• In an article published in sociology compassTimothy Andrews and Katie Wright of La Trobe University analyze challenges that hinder the use of psychedelics in medicine, such as social stigma and the criminalization of psychedelics. But deregulation of psychedelics poses additional problems, argue Andrews and Wright. They argue that if psychedelics were decriminalized, the lines between therapeutic and recreational use could blur, creating problems regulating the administration of psychedelics by physicians. .
• recently Harvard Law Review Essay, I. Glenn Cohen and Glenn Cohen and Mason Marks, Petri Fromm Center for Health Law Policy, Biotechnology, and Bioethics Center at Harvard Law School Facilitating the Issuance of Psychedelic Patents Where U.S. Patent Law Does Not Meet Regulatory Requirements I’m looking for a way I could be. Cohen and Marks argue that many psychedelic patents have been disqualified under the United States Patent and Trademark Office (PTO) approval requirements. Cohen and Marks explain that many psychedelic substances are excluded because naturally occurring substances fall outside the PTO’s patentable subject matter. They argue that these requirements encourage patent applicants to “manipulate the system” and engage in malicious acts to gain approval. Cohen and Marks argue that PTO agents’ lack of expertise in psychedelic substances is an additional impediment that results in an increasing number of inappropriate patents being granted without proper scrutiny. .
• In an article published in Risk management and healthcare policyRafael Guimaraes dos Santos and several co-authors from the University of São Paulo discuss the cultural and religious uses of psychedelic drugs in different cultural contexts, shaping the possibilities of psychedelic treatments in future health policy. According to Dos Santos and his co-authors, studies conducted in cultural contexts where drug use is ritualistic or medical, rather than recreational, have found relief in anxiety and depression, Health benefits are seen, such as reduced dependence on prescription drugs, improved psychosocial adjustment, and more. We need to choose a progressive, regulation-oriented approach to psychedelics, rather than one that is oppressive and punitive.
• In an article published in American Journal of Medicine, Matt Lamkin of the University of Tulsa Law School, analyzes the barriers to incorporating psychedelics into clinical practice. Despite promising psychedelic research in the mid-20th century, the CSA effectively banned psychedelics and stifled research, Lamkin explains. Lamkin argues that even if a psychedelic drug does get FDA approval, it cannot be legally prescribed because of its status as a Schedule I substance. also explains that some states may require regulatory action or new laws before such drugs can be legally prescribed.
• In an article published in Journal of the American Medical AssociationWilliam R. Smith of the University of Pennsylvania Perelman College of Medicine and Paul S. Appelbaum of Columbia University Baghelos College of Physicians and Surgeons look at California and Oregon as two examples of psychedelic legalization. Oregon was the first state to legalize the clinical use of psilocybin, and California proposed a bill to legalize possession, personal use, and noncommercial sharing of hallucinogens by adults, Smith and Appelbaum say. However, they argue that the rapid legalization and commercialization of psychedelics can be detrimental. time to properly assess the evidence of potential risks and ensure that policy makers and the public have the information they need to formulate prudent regulatory policies.